FDA approves Par Pharmaceutical's new painkiller drug

Nov 17 2009

Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER. Ortho-McNeil sells extended-release tramadol tablets under the brand name Ultram® ER. Par has been awarded 180 days of marketing exclusivity, commencing at launch, for being the first to file an ANDA containing a paragraph IV certification for the product. Annual U.S. sales of the 100mg and 200mg strengths of Ultram® ER are approximately $156 million, according to IMS Health data. Par began shipping tramadol ER to the trade upon approval.

In August, Par announced that the U.S. District Court for the District of Delaware ruled in favor of Par in its challenge of Purdue's patents relating to extended-release tramadol, which are listed in the Orange Book for Ortho-McNeil's Ultram® ER product.

Important information about Tramadol ER

Tramadol hydrochloride is a centrally acting synthetic analgesic in an extended release formulation. Tramadol hydrochloride ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Tramadol hydrochloride ER tablets should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. Tramadol hydrochloride ER tablets are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. Tramadol hydrochloride ER tablets may worsen central nervous system and respiratory depression in these patients.